MYO-DEN (30 ml) 25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Recall Number: D-1739-2015
Firm: The Compounding Pharmacy of America
Classification: Class II
Status: Terminated
Report Date: 20150923
Initiation Date: 20150602
Termination Date: 20160210
Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product Description
MYO-DEN (30 ml) 25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN